Eleven million doses of polio vaccine containing material from British cattle have been administered to children and adults since BSE vaccine guidelines banned its use in 1989, the Department of Health said yesterday.

Hundreds of thousands of polio doses were withdrawn after the department decided that assurances given by Medeva, the supplier, had "proven inaccurate". Professor Liam Donaldson, the Chief Medical Officer, said that the risk of being infected with vCJD, the human form of mad cow disease, was "incalculably small".

He said: "I know that this recall will worry parents, but it is important to remember that polio is a potentially lethal disease which we have virtually eliminated from this country. However, public confidence in medicines safety is paramount. We have to approach this from a precautionary principle, knowing that these important guidelines have been breached."

Production of the vaccine ceased last month, but supplies continued to be sent to doctors. Because the guidelines have no legal force, no action can be taken against Medeva. The Department of Health is furious that it has been forced to withdraw the vaccine, knowing the sensitivity of parents to such scares. After reports that the measles vaccine could be linked to autism, levels for the measles, mumps and rubella vaccination dropped from 91.5 per cent in 1997 to 87 per cent last year.

Jackie Fletcher, of JABS, a group for parents concerned about vaccines, said: "It is not good enough just having regulations. They have got to be enforced. There needs to be transparency and there needs to be less trust and greater checking of drug companies."

Dr Liam Fox, the shadow health secretary, said: "The immunisation programme is one of the most important parts of public health policy. It is therefore essential that all information is fully disclosed by the Government to help retain the confidence of an understandably sceptical public."

Nick Harvey, the Liberal Democrat health spokesman, said it was crucial that children continue to be vaccinated. He added: "The Government's vaccine programme is in confusion and disarray."

Since 1989 the Medicines Control Agency has sought assurances from drug companies that bovine material from Britain was not being used in vaccines. Oral vaccines, such as the polio vaccine, were not specifically mentioned . European guidelines issued last year outlawed bovine material from Britain being used in oral vaccines. But they will not have the force of law until March 2001 .

A statement from the Department of Health said: "The implementation of this [1989] guidance led to a phasing out of vaccines using UK-sourced bovine material. The MCA sought and received assurances from drug companies that they were implementing this guidance. The MCA has now advised ministers that in the case of Medeva oral polio vaccine the assurances have proven inaccurate."

The statement continued: "This oral vaccine was manufactured using a growth medium containing material of UK bovine origin . All GPs were told to withdraw the vaccine immediately."

The vaccine has had a chequered ownership. First produced by Wellcome, it was sold to Evans Medical in 1991, which became part of Medeva. Celltech acquired Medeva in January and then, on Oct 1, sold it to Powderject. Wellcome and Glaxo merged in 1995.

Powderject said it had not, and had no intention of, making or selling Medeva polio vaccine. GlaxoWellcome said that the 1989 guidelines referred to injected vaccines. Celltech said it could not understand why the Government had acted now as it had had the information for a month .

Dr Peter Fellner, chief executive of Celltech, said: "We are absolutely astonished and amazed by the statement from the Department of Health . We feel that we have been unfairly put in the frame for a situation which has nothing to do with the actions of people during the period in which we owned the company."

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21 Oct 00 - CJD - Bone meal did get into cattle feed, say French

By Harry de Quetteville in Paris

Telegraph ... Saturday 21 October 2000

French officials admitted yesterday that they allowed potentially infected bone meal into cattle feed, undermining measures to prevent the spread of BSE .

The practice, banned in France since 1990, is suspected as being one of the primary vectors of BSE . Revelations in the French newspaper Liberation provide dramatic evidence to support a British expert's claims that British beef is safer than French.

They also expose as baseless the much-vaunted "precautionary principle" with which the French government justified the ban on British beef. In the report, the authority that monitors French cattle feed admitted its policy was to overlook small quantities of bone meal. An official from the French department of consumer and competition fraud said: "We consider animal feed with more than 0.3 per cent bone meal not to comply with regulations."

This would suggest that feed containing up to 0.3 per cent bone meal is permitted , in direct contravention of French law. But a spokesman for the French agriculture ministry insisted: "Bone meal is prohibited and there is no law whatever permitting any tolerance."

The news prompted an outcry among Greens who form part of the Socialist coalition government led by Prime Minister Lionel Jospin. Spokesman Dennis Baupin said: "The revelations throw a terrible cloud of suspicion over both the state regulators and the beef itself, the health consequences are incalculable ."

Vincent Perrot from the Consumers, Housing and Lifestyle Association said: "No one knows the dose one has to consume to be infected. We have to stop playing with consumers' health."

Despite the French agriculture ministry's supposedly stringent measures, cases of BSE have continued to rise in France. In April, the agriculture minister Jean Glavany suggested that, given French precautions, the rise in cases could only be explained by the existence of "a mysterious third way" of transmitting the disease. Other than through infected cattle feed, BSE can also be passed from a cow to its calf.

M Glavany's view was directly contradicted in a European Commission report earlier this year which showed that 4.2 per cent of French cattle feed contained traces of bone meal .

21 Oct 00 - CJD - A few drops that let the Western world forget polio

By Fred Kavalier

Independent ... Saturday 21 October 2000

Yesterday's sudden withdrawal of polio vaccine has catapulted the disease from obscurity into the headlines.

Hardly anyone in Britain under the age of 45 knows anything about polio, because in 1955 vaccination against the paralysing virus was introduced and within five years it virtually disappeared. But before this, polio struck fear into families.

When the vaccine came along, it was eradicated in the developed world almost overnight. In the UK, there were only 28 confirmed cases between 1985 and 1994.

Unfortunately, the latest scare is likely to create a new kind of worry in the minds of parents. Although the Department of Health is adamant that the risk of catching BSE from the withdrawn polio vaccine is infinitesimally small, any bad publicity about vaccines is bound to put people off the idea of all vaccinations.

The irony is that most of the recent cases of polio in the Western world (19 of the 28 British cases and 124 of the 133 American cases) have been caused, not prevented, by the very vaccine designed to prevent the disease . How can this happen?

The first polio vaccine consisted of killed polio organisms. A series of three or four injections provided full protection, with no risk of causing the disease. A few years later, in 1961, a new "live" vaccine was developed. This vaccine contained living polio viruses, and it could be given by mouth. Although it carried a theoretical risk of inducing polio as a disease, this was such a remote possibility that by the mid-Sixties it was a first-line vaccine against polio. Its success has been astounding. In the UK, there has not been a single confirmed case of indigenous (not imported from abroad) "wild-type" polio for more than a decade.

But even in countries with vaccination programmes, there have remained a stubborn few cases of polio. Most of them were caused by the "live attenuated" virus contained in the oral vaccine.

In America last year, it was recommended that children be immunised with the original "killed" vaccine. France and Germany have moved away from the live vaccine.

Although there is honest disagreement among British experts about the best way forward, there is huge agreement that immunisation of British children against polio remains essential until polio joins smallpox in the archives of history.

21 Oct 00 - CJD - Wanted: a vaccine to fight fears over the health of children

Public confidence in the safety of immunising millions of British children each year has reached an all-time low and could lead to epidemics of crippling childhood diseases, doctors warned yesterday.

The recall of the polio vaccine because of fears of mad cow disease is the latest in a spate of scares about the vaccination programme, which includes concerns about the combined measles, mumps and rubella (MMR) vaccine.

Public health officials and medical experts warned that increasing numbers of parents refusing to immunise their children could lead to a return of killer diseases, such as polio, tuberculosis, diphtheria and rubella, that have all been eradicated from the Western world.

Parents of vaccine-damaged children said increasing numbers of people were questioning the vaccination programme because of the secrecy of drug companies and the unwillingness of the Government to recognise concerns or investigate fears over the safety of different jabs.

The Government's Medical Control Agency ordered the recall of a polio vaccine that has been used to inoculate millions of children after it was discovered that it had been produced using foetal calf serum from Britain .

Liam Donaldson, the chief medical officer, said the risk of contracting vCJD, the human variant of BSE, was "incalculably small" but the vaccine was being removed as a precautionary measure. The Government said the recall was based on the discovery of a breach of European guidelines issued in 1999 as precautionary measure to protect public health in the light of developing information about the theoretical transmission of BSE.

However, guidance on the use of bovine materials for oral medicinal products was issued in the first BSE report produced by Sir Richard Southwood in 1989, which stated: "The Licensing Authority has been alerted to potential concerns about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now take account of BSE agent."

The latest disclosure about the polio vaccine will intensify the embarrassment over BSE in light of next week's official report, which is expected to expose years of Whitehall concealment over the scandal .

After the Southwood report, guidance was produced by the Committee on Safety of Medicines in 1989, which said UK-sourced bovine materials should not be used in the manufacture of injectable medicinal products. As a result, vaccines using material from cows or calves in the UK were phased out during the early Nineties.

The Department of Health said it repeatedly "sought and received" assurances from Medeva, the company which made the polio vaccine, that UK bovine material was not being used in the production.

But suspicions were raised in June that the guidelines were being breached and further investigations revealed that UK-sourced foetal calf serum was being used as a growth agent in the vaccine.

The vaccine has been used in the UK since the early 1980s and, until September, accounted for a third of inoculations, around 11 million, given to children, travellers and other patients in this country.

Professor Donaldson said he recognised the recall would worry parents. "It is important to remember that polio is a potentially lethal disease which we have virtually eliminated from this country," he said. "Only by keeping children vaccinated can we ensure that it does not return to this country."

He added: "Public confidence in medicines safety is paramount. We have to take a precautionary approach, knowing these guidelines have been breached. The vaccine will be recalled immediately and replaced with a one which meets safety requirements."

Isabella Thomas, of JABS, an organisation that was established seven years ago byparents of vaccine-damaged children, said the latest scare would put even more parents off immunising their children.

"Parents are starting to question the vaccination programme, there are so many unanswered questions . It is not good enough for the Government to say it tried to check with the company. More needs to be done, we need more openness and more safeguards .

"There is too much secrecy. You have one lot of doctors saying the vaccines are safe and another lot saying they are not and it is the children who get caught in the middle."

Most JABS members are parents who believe their children suffered adverse reactions to the combined MMR vaccine, but other cases include the whooping cough, meningitis C and polio jabs. Mrs Thomas, who has two sons she believes have been damaged by the MMR, said children given the MMR jab had become deaf, developed diabetes, autism, epilepsy, chronic bowel disease and other health problems.

A spokesman for the Department of Health said the Government was worried about the impact the latest scare would have on the public health and vaccination programme. "We have achieved over 95 per cent coverage for most diseases, but the MMR vaccine coverage is still too low," he said.

The childhood vaccination programme includes diphtheria, polio, tetanus, whooping cough, measles, mumps and rubella. Concerns about the MMR vaccine have resulted in vaccination levels among young children falling from 95 per cent to 88 per cent in the past three years.

There have also been reports that 11 children have died and 16,000 have suffered adverse reactions after being given the meningitis jab since it was introduced last November.

However, doctors warned that it was easy to forget that only 40 years ago measles epidemics regularly struck about half a million children and as late as 1955 there were nearly 4,000 cases of polio in England and Wales. Between 1980 and 1995 there were only 28 cases of polio in Britain.

"Surely no one wants to go back to the situation we had in the 1950s when thousands of people were devastated by polio," said John Grounds, director of the charity Action Research. "We are within a whisker of eradicating polio worldwide. We can understand parents are concerned, but the risks are small and we would urge people to continue to have their children immunised."

Dr Simon Fradd, joint deputy chairman of the BMA's General Practitioners Committee, said: "The risk from any outbreak of polio, if immunisation levels fell off, would be very much greater. I would urge parents to continue having their children immunised."

A polio vaccine that has been given to millions of children and adults was withdrawn by the Government yesterday amid fears it could be contaminated by mad cowdisease .

The Medical Control Agency ordered GPs to return all unused doses after the finding that it had been produced using foetal calf serum from the UK.

Guidelines in 1989 banned the use of bovine material in medicinal products, but despite repeat assurances from Medeva, the maker, the Department of Health found it was in breach of the guidelines.

The company, which has made one-third of polio vaccines used in Britain since the early 1980s, stopped producing the vaccine last month.

Dr Peter Fellner, chief executive of Celltech, which bought Medeva from Wellcome and owned it from January to October this year, said records relating to the batch of vaccines in question did not "fully clarify" its BSE-free status. "We had assurances from Wellcome that there were no issues over the vaccine and passed on these assurances to the Department of Health. What Wellcome told us was found not to be accurate," he said.

Professor Liam Donaldson, the chief medical officer, said the risk of anyone being infected with vCJD, the human form of BSE, was "incalculably small". The recall comes as it was announced that a report into Britain's BSE crisis will be published next week after a 30-month inquiry.

Medical experts urged parents to continue getting their children immunised, warning that any fall in vaccination levels could result in polio returning to this country for the first time in decades. Worried parents and patients have been advised to see their GPs or contact NHS Direct.

Despite the obvious breach of the guidelines, which were updated in 1999, no action can be taken against any company as the guidance does not become legally binding until next year when it will be covered by an European Union directive.

Andrew Kemp, chief executive of the British Polio Fellowship, which supports victims, said: "What we would hope is that this does not deter anyone from being vaccinated. The vaccine has been extremely successful in combating polio."

Liam Fox, the shadow Health Secretary, said: "The immunisation programme is one of the most important parts of public health policy... It is therefore essential that all information is fully disclosed by the Government to help retain the confidence of an understandably sceptical public."

21 Oct 00 - CJD - Cow remains 'permitted' in French cattle feed

By John Lichfield in Paris

Independent ... Saturday 21 October 2000

Further evidence emerged yesterday that France ignores its own purported policy of zero tolerance of the risks associated with BSE, or mad cow disease .

Liberation, a French newspaper, reported that traces of the ground-up remains of cows were permitted in French cattle feed, despite an official ban going back 10 years.

For the past two years, French customs and fraud officers have been ordered to allow the use of compound cattle feeds containing 0.3 per cent or less of minced and dried remains of cows and other grazing animals . The presence of cow remains in cattle feed is blamed for the epidemic of BSE in Britain. It has been banned from cattle feed in all European Union countries since 1990.

The French feed industry argues that it is difficult to test the contents of cattle feed to an accuracy of less than 0.3 per cent. Feed manufacturers also say it is impossible to guarantee that feed is 100 per cent clear of cattle remains. Unlike the UK, France continues to allow the use of dried cattle remains in feed for pigs and hens .

Scientists have warned that BSE transmission through feed is a complex, ill-understood subject. Some animals can eat large quantities of suspect feed and not catch the disease; others might succumb to exposure to tiny amounts of infected feed.

The disclosure of an official French policy of "tolerance" of BSE risk - however small - undercuts the main argument used by Paris a year ago when it defied EU orders and imposed a unilateral ban on British beef imports. The French government said it had to pursue, where possible, a policy of zero risk with human health.

Since then a number of instances have emerged of French policy on BSE taking risks when tighter controls might damage agricultural or food trade interests. A French consumers' association yesterday called on the government to "stop taking risks with human health" and ban use of cattle remains in all animal feed.

Claims earlier this week that French beef is now less safe than British have been dismissed as misleading by French officials, who say that France has had only 152 cases of BSE in the past decade compared with 180,000 in Britain.

21 Oct 00 - CJD - BSE risk in polio vaccine revealed

James Meikle and Andrew Clark

Guardian ... Saturday 21 October 2000

The government last night faced calls to tighten controls over the medicine industry as it admitted that children were still being given oral polio vaccines using material from British cows 14 years into the BSE crisis .

Officials have been forced to recall remaining supplies of the drug as a precautionary measure, while insisting that the risk of catching the human form of BSE through innoculation was "incalculably small".

An estimated 35m doses of the vaccine produced by Medeva between 1991 and this week have been given to young children, teenagers receiving booster doses and travellers. It accounted for a third of all oral polio vaccine administered.

Guidelines to ban the use of bovine material from BSE-affected countries in vaccines have been in place since 1989, three years after BSE was identified. Until last year these were primarily aimed at those injected into people, but the Department of Health said the spirit of the measures was meant to apply to oral treatments as well. There was unlikely to be any legal action against the suppliers because guidelines are not finally turned into law until next year .

The health department said assurances by the company had "proven inaccurate" but it was vital that parents continued to have their children vaccinated against polio as part of a £4m-a-year national programme to keep at bay a potential killer that has virtually been eliminated in Britain.

The news horrified families of the 84 victims of variant CJD, the human form of BSE, because the possibility that vaccines were a cause of the fatal disease in humans has been examined by the BSE inquiry which reports next week.

Malcolm Tibbert, chairman of the Human BSE Foundation, said: "After all these years it still looks as if we have not learned any lessons. It transpires the Department of Health didn't check out these companies to proper standards. It is very worrying ."

Norman Baker, the Liberal Democrat MP for Lewes, who has been campaigning for the government to give more information on vaccines, said: "There has been a terrible averting of eyes on anything related to vaccines in the last 11 years. The whole reason seems to be that the vaccination programme must not be undermined. I am happy to accept BSE is a remote risk but [the Department of Health's] response has been to sweep it under the carpet."

Liam Donaldson, the chief medical officer for England, said the impact of the recall was likely to be minimal. "I know this recall will worry parents but it is important to remember that polio is a potentially lethal disease which we have virtually eliminated from this country.'

"I am advised that the risk of a person contracting vCJD from this oral polio vaccine is incalculably small. Public confidence in medicine safety is paramount. We have to approach this from the precautionary principle, knowing that these important principles have been breached."

Vaccine production uses foetal calf serum, from pregnant cows, to help grow cells using different polio strains. A vaccine using the British material was put on the market by Wellcome in 1989. But in 1991 it was bought by Medeva, which added two strains of its own to a new product.

This became part of the huge Celltech business early this year but was sold on to Powderject Pharmaceuticals this month. Celltech said yesterday it had "relied on assurances from Wellcome" that the product came from overseas cattle when it said on three occasions in the 1990s that it did not use British sources.

• Worried patients should contact their GP who will hold records of which brand of vaccine has been given. Alternatively, they can call the NHS Direct helpline on 0845 4647.

21 Oct 00 - CJD - Vaccine fiasco exposes loopholes

James Meikle

Guardian ... Saturday 21 October 2000

Another crisis linked to the inquiry into BSE forces the medical industry to re-examine its guidelines on just what is safe

As GPs set aside thousands of doses of Medeva oral polio vaccine, the government was battling once more to maintain confidence in its immunisation programmes.

The latest in a series of fiascos leaves health officials conceding that voluntary measures agreed with the drug industry failed to keep bovine material from BSE-infected Britain out of vaccines. This follows controversy over the measles, mumps and rubella (MMR) jab, linked to autism and Chrohn's disease, and the new meningitis C vaccine.

Once again the government is having to stress how its programmes keep potentially lethal disases at bay, and to put this above the risk, apparently minimal, of infecting children with other killers.

The Medeva case is slightly different however. The government has in recent months kept saying the bovine materials in its vaccines were sourced from BSE-free countries. It had to, after it emerged from the BSE inquiry that guidelines issued as long ago as 1989 telling drug companies to change their supplies, had in fact taken up to four years to work through. Stocks of vaccines for MMR, diptheria, tetanus and whooping cough had to stay in use to ensure programmes could continue until replacements were ready.

Unfortunately, the guidelines only ever referred to injected vaccines until new guidlines emanated from the EU last year and got British approval in April. Next year, for the first time they will have the force of law. But the government maintains the spirit of the guidelines was meant to apply to all vaccines.

Yesterday's revelations were hugely embarrassing for the health department and its medicines control agency. It appears three times to have relied on assurances from Medeva, and Medeva claimed to have relied on assurances from Wellcome from whom it bought part of its product in 1991. Foetal calf serum helps "grow" strains of polio virus, which helps produce antibodies in those vaccinated to fight the disease itself. Polio vaccine involves three strains. Work on one in both the Wellcome and Medeva product, involving a British source, seems to have been under way in 1985, the year before BSE was formally identified in herds, and four years before it actually went into commercial use. No one yesterday could say how many doses were administered between 1989 and 1991 .

But Medeva's product involved blending two strains from non-British sources and has been administered in 35m doses. It said six batches of a third strain manufactured by Wellcome had come from BSE-free herds in New Zealand but a seventh had come from a controlled British herd.

The government yesterday insisted that serum from BSE-infected cows did not display infectivity and that the manufacturing process would remove unwanted protein. The risk of tranferring BSE infectivity into humans was therefore "incalculably small".

Experiments on mice innoculated with infected British cattle serum are thought to have so far shown no evidence that BSE can be transmitted in this way but scientists have long known of the theoretical possibility that it may be.

Evidence to the BSE inquiry suggested officials responsible for the control of medicines had been considering such dangers as early as autumn 1987 , even though the health department was not officially informed even of the existence of BSE until March 1988 .

Sir Donald Acheson, then the chief medical officer, was worried, but he was even then concerned about the threat to vaccination programmes. He told the BSE inquiry there were 180 deaths from measles and whooping cough in the 1980s because some babies had not been vaccinated in the wake of other scares. In Febrauary 1989, there were found to be more than 500,000 litres of medicines in stock using British bovine material .

The following year it was known that at least three products were still made that way - a skin test for TB, a measles vaccine and a vaccine to prevent diptheria, tetanus and whooping cough.

But even last year the identity of the companies was protected by confidentiality clauses in the medicines act . It is understood however the inquiry report next week will give names. It has subsequently emerged there were probably five vaccines that involved British-sourced serum with expiry dates in 1992 or 1993, although the health department could not provide exact dates.

Now Celltech, the company which absorbed Medeva, and has just sold the vaccine business, says it acted in good faith and in a manner consistent with its knowledge. It is aggrieved that it told the control agency of the problem but was not even been informed of yesterday's recall notice.

The reddest faces will be within government however, and questions will be asked once more about just how independent and efficient the regulatory system truly is.

21 Oct 00 - CJD - Warning over BSE link made in 1989

By Nigel Hawkes Health Editor

Times ... Saturday 21 October 2000

Senior government advisers said as early as 1989 that vaccines could provide a route by which BSE could be transferred to human beings.

Their fears were brushed under the carpet because the Department of Health was worried that any adverse publicity about vaccines could cause a panic, with parents refusing to have their children vaccinated. The true feelings of those involved have emerged through evidence given to the BSE inquiry under Lord Phillips of Worth Matrvaers, which is due to publish its report next week.

Sir Richard Southwood, who led the first inquiry into BSE in 1988, soon identified that the greatest risk of human transmission lay in the injection of contaminated material in vaccines , and identified this as a priority area for action. In a meeting in May 1988, the Government's chief medical adviser, Donald Acheson, called for "urgent advice".

Sir Richard wrote a letter circulated to officials in which he said "the possibility of human infection is moderately high" . He also wrote to the Committee on the Safety of Medicines three times asking for action. But his report played down the threat by saying that the risks "appeared remote". He told the Phillips inquiry that the committee used reassuring language because it did not want to cause a flight from vaccines and have the deaths of children on their consciences.

They were also told privately by the Health Department that steps would be taken to reduce the risks. But in writing to the vaccine manufactures, the department merely reiterated that the risks of infection through medical products was remote. In January 1989, the CSM ruled that future vaccines would be taken only from herds certified to be free of BSE, but took no action to remove stock from the shelves made before this change was introduced. The vaccines continued to be used until 1993, and included MMR (measles, mumps and rubella) and vacccines against diphtheria, tetanus and whooping cough. Norman Baker, the Liberal Democrat MP who has campaigned on the issue, says this was "potentially criminally negligent ".

The Health Department says that if vaccinations had been stopped there would have been a risk of epidemics, and deaths, among children. This risk was real, while that of transmission of BSE was "remote and theoretical".

Health ministers have given evidence that they were never properly briefed . Kenneth Clarke, a former Secretary of State for Health, has said that had he been told he would have ordered the vaccines to be withdrawn. So far, no evidence has emerged which implicates the vaccines in variant CJD, the human form of BSE, which has claimed 75 lives. Most scientists still believe that eating contaminated beef is a more likely source, although the young age of many vCJD victims has led others to suspect a role for vaccines.

The latest alarms over the oral polio vaccine do not change the picture. Even if it was contaminated, eating the infective agent for BSE is less dangerous than being injected with it. Celltech, which now owns Medeva, the company responsible for the vaccine, and the Health Department believe the risks from the vaccine are "incalculably small". Credibility of government assurances in this area is not very high .

Vaccines are often made from weakened versions of the agent responsible for disease. Such so-called live viruses can stimulate the immune system to fight the disease but are not strong enough to cause it. As living organisms, they have to be grown in cultures. Foetal bovine serum is widely used for growing vaccines - but if it comes from BSE-infected cows, it has the potential to produce a vaccine which might carry the infective agent .

21 Oct 00 - CJD - Risks of polio outweigh risk from vaccine

Staff Reporter

Times ... Saturday 21 October 2000

How many doses of vaccine are affected?

Medeva and Wellcome have produced about 11.5 million doses of oral polio vaccine since 1989, according to the Department of Health. It was produced in seven batches, six of which are confirmed free from BSE, but it is unclear whether the batches were mixed before being split into individual doses. If the batches were mixed, all 11.5 million doses could be affected. If not, the figure is more likely to be between one and two million doses.

Who is vaccinated against polio?

About six million doses of vaccine, costing £4 million, are used every year, mostly on children: 96 per cent are now immunised by their second birthdays. Travellers going to areas outside North and Western Europe, North America, Australia and New Zealand are also advised to take the vaccine if not already immune.

How can you find out who has had the Medeva vaccine?

The NHS stopped using the vaccine last month. The department says that before that, some areas of the country are likely to have bought more Medeva vaccine than others, and is trying to trace which ones. GPs record batch numbers when they receive supplies of vaccine and can check them to find out the source. The vaccine was first used in 1989, so anyone vaccinated before that should be clear.

Is there a problem with vaccines still in use?

No. Remaining stocks of Medeva vaccine are being recalled. SmithKline Beecham, which makes the majority of the UK vaccine supply, says it has large enough stocks to cover demand.

Is vaccination against polio really necessary?

Doctors think it is. The disease has been eradicated from Britain because of vaccination and to stop it would bring new risks. In 1993, an outbreak struck a religious group in The Netherlands who opposed vaccination.

21 Oct 00 - CJD - BSE fears over polio vaccinations

By Nigel Hawkes Health Editor

Times ... Saturday 21 October 2000

Hundreds of thousands of doses of a polio vaccine were recalled yesterday as the Department of Health considered legal action against a drug company amid fears over "mad cow" disease.

(UK Correspondents note: there is no possibility of legal action as using UK bovine material will not BE ILLEGAL untile March 2001)

The vaccine, used to treat up to 11.5 million children and adults over the past two decades - a third of all such vaccinations - was recalled after the Government's Medicines Control Agency found that it had been produced with material from British cows, in breach of European guidelines in force since last year. Professor Liam Donaldson, the Chief Medical Officer, wrote to GPs instructing them not to use remaining vaccine.

The Department of Health accused Medeva, the manufacturer, of giving it "inaccurate assurances" that the vaccine followed guidelines. Medeva countered by accusing Wellcome, which originally made the vaccine, of misleading it, and the Government of dragging its feet over the recall.

The actual risk, all sides agree, is tiny. Professor Dondaldson said that the risk was "incalculably small".

He said: "Public confidence in medicines safety is paramount. We have to approach this from a precautionary principle."

Dr Peter Fellner, the chief executive of Celltech, the company that owned the Medeva vaccine operation until the beginning of this month, said it had received assurances from Wellcome "that there were no issues over the vaccine".

The company said that it had discovered the truth when it finally gained access to Wellcome's files and found that a batch of vaccine had been made using foetal bovine serum - a growth medium - that came from a herd in Britain. There is no evidence that the herd had exhibited any signs of infection with BSE. The guidelines banning that serum do not have the force of law , although they will do so from March next year, so Medevacannot be prosecuted for breaching them. A DoH spokeswoman said, however, that "if it can be proven that we were misled" some legal action could be taken.

Dr Fellner said: "We wrote to the DoH on August 17 informing them of this and correspondence continued up until last week."

The Government said that supplies of polio vaccines would not be adversely affected. Smith Kline Beecham, which supplies two thirds of doses, confirmed that it had supplies to meet demand. Andrew Kemp, chief executive of the British Polio Fellowship, said: "What we would hope is that this does not deter anyone from being vaccinated."

20 Oct 00 - CJD - A history of incompetence and complicity

James Meikle

Guardian ... Friday 20 October 2000

We should not be surprised to learn that material from British cows has been used in polio vaccine throughout the BSE crisis

Today's shocking revelation that a common polio vaccine grown using material from British cows has been in use since early in the BSE crisis should perhaps not really be so surprising.

The history of incompetence in identifying and managing risk , and a tendency to cohabit with the beef industry rather than with consumers displayed by agriculture and health officials during the crisis, has been glaringly exposed during the two year BSE inquiry whose report is published next week.

The possibility of people catching a human form of the incurable cattle condition from medicines was identified by some advisers as early as autumn 1987 but the then chief medical officer and his ministers were not informed even of the disease until March 1988 .

Since 1989 there has been a succession of guidelines from Whitehall and, later, Brussels on sourcing material, usually calf serum for growing vaccines, from countries which have no history of BSE. But only in March next year will these have the full force of law.

More surprisingly, EU guidelines have explicitly covered oral vaccines - as well as injected alternatives - only since 1999 . Nevertheless, the spirit of the guidance was always meant to cover all types.

It has been taken largely on trust that the medicines industry follows such guidance. Until very recently, it hid behind confidentiality clauses when journalists or the public tried to find out how many products still used British-sourced cattle products . The health department has always argued that scares about vaccine safety would be more dangerous than what it first called the "theoretical", and more recently "remote", risk of BSE infection, as huge numbers of parents might stop inoculating their children. It therefore allowed stocks of vaccines using British bovine sources to be used well into the 1990s without even telling the public about the concerns .

But its pathetic excuse over the Medeva polio vaccine - that "the assurances by the company have proven inaccurate" - shows just how poor the regulation of drugs really is . Most scientists in the field do not believe that vaccines are the cause of the present human BSE epidemic, which has so far killed 77 Britons and infected seven others.

But conspiracy theorists who believe the government was happier to let the farming industry endure years of penury and penitence for feeding Britons poisoned meat rather than see profitable pharmaceutical companies embarrassed will have had their worst suspicions confirmed .

20 Oct 00 - CJD - A new official secrecy scandal

by Christopher Hudson

Evening Standard ... Friday 20 October 2000

That knocking sound you hear is the noise of the Government battening down the hatches.

The news, slipped out so quietly, that "bovine products" have continued to be used in a polio vaccine has been cocooned in all those weasel phrases with which we have become familiar since the Tory health minister, Stephen Dorrell, stood up in the House of Commons to admit to a slight problem over bovine spongiform encephalopathy.

The Chief Medical Officer, Professor Liam Donaldson, is announcing the recall of the Medeva polio vaccine purely as a "precautionary measure" , we are told. He has been "advised" that the risk of anybody contracting variant Creutzfeldt-Jakob disease from this oral vaccine, given on a sugar lump, is "incalculably small" . And anyway, we have to remember that polio is a potentially lethal disease, which polio vaccines have virtually eliminated from this country.

Remove the cotton wool from this statement and what do we have? No less than 12 years after the Southwood Report noted this very danger, and recommended that vaccines be prepared using the tissues of animals other than cattle, a polio vaccine routinely given to travellers and to children in Britain's nationwide vaccination programme is found to contain material from cows which could infect an indefinite number of millions of people.

What are parents supposed to think? CJD can take at least 10 years to reveal itself. Parents who have crossed their fingers and prayed that the hamburgers and sausages eaten by their children when they were small have not infected them now have to consider the possibility that a vaccine provided to protect them from one disease might be responsible for giving them a far more lethal one .

And they know - we all know - that without the delays, cover-ups and sheer mendacity shown by this Government and the last one, it need never have happened.

The Ministry of Agriculture, Fisheries and Food sowed the wind when it declined to make Sir Richard Southwood's recommendation a statutory requirement , and satisfied itself by announcing "guidelines " instead. Now it is reaping a whirlwind which will rage through its corridors. MAFF and the Medicines Control Agency knew that they had to rely on the probity of companies involved in making vaccines and other injectable medical products.

Having "sought assurances" from the drug companies concerned, they now discover that in the case of the Medeva vaccine, "the assurances by the company have proven inaccurate" .

The entire history of BSE in Britain - since 1986 when scientists told MAFF exactly what was wrong with the first herd of BSE-infected cows in southern England, and were immediately warned that if they published any papers on the subject, or so much as talked about it, they would get the sack - has been riddled with lies .

You may recall that for the next 15 months, MAFF officials continued to recommend to farmers the feed, containing bovine offal, which they knew might be responsible for the BSE. Not until March 1988 did anyone in MAFF bother to inform the Chief Medical Officer. Not until July was the decision taken to destroy carcasses; not until August that year did the order go out to slaughter cattle and compensate farmers.

By 1996, when the Government finally went public on the possibility of a link between BSE and CJD, the first-known CJD victim, Stephen Churchill , was already dead.

All along the line, the Ministry continued to drag its feet . It barred the Public Health Laboratory Service from getting involved in the BSE scare, fearing that if the Laboratory Service was called in it would signal a concern in Whitehall that people were at risk from contaminated meat. When, in 1988, two doctors raised this very concern in the British Medical Journal, an official from MAFF went on the radio to say that transmission of BSE to humans was as "unlikely as being struck by lightning" .

Now, in language so similar as to send a shiver up the spine, we are told that the danger of contracting vCJD from potentially infected polio vaccine is "incalculably small".

Of course the danger is small: the trouble is that it exists; it could affect any of us and particularly our polio-vaccinated children; and it could have been avoided if this Government and the last one were not so wedded to their culture of secrecy .

New Labour came to office promising a Freedom of Information Bill . In its latest, truncated form, this Bill is a mockery of what the Home Secretary, Jack Straw, originally proposed.

At every turn, the first instinct of this Government is to conceal anything and everything it can get away with . It is secretive on the big things, like arms sales, and on the small ones, like the Price Waterhouse report on the financial background to the Dome and on a similar report on the public-private partnership for the London Underground, which was commissioned by that most secretive of Cabinet ministers, the Chancellor, Gordon Brown.

In most cases, this malaise of concealment does not apply to life-and-death issues, but on BSE it has caused incalculable distress .

So far, it is thought that 69 people have been killed by variant Creutzfeldt-Jakob disease, with another eight more "probable" cases of it, including the youngest potential victim so far, a 12-year-old girl .

According to a letter in The Lancet from Edinburgh's national vCJD surveillance unit, the number of people contracting the disease has gone up by 23 per cent every year since 1994 . In the first six months of this year alone, 14 people died of it.

The Government must now come clean. We need to know exactly how many people have been given the Medeva polio vaccine. We need to know the exact circumstances in which the manufacturing company continued to use bovine material to make it. And we need a shakeout of the Ministry of Agriculture, Fisheries and Food, from top to bottom.

20 Oct 00 - CJD - Drug firm behind the scare

by James McLean

Evening Standard ... Friday 20 October 2000

The drugs company at the centre of the polio vaccine withdrawal scandal was today chasing through more than a decade of records for details of a herd of British cows from which the suspect vaccine ingredient was sourced .

Celltech, which produced the vaccine via its then subsidiary Medeva, sold this month, said the rogue component derived from stocks inherited from drug giant Wellcome. Wellcome sold the Medeva vaccines unit to Celltech in 1990.

Celltech said: "It has been established that six batches of this strain were manufactured by Wellcome using bovine serum albumen sourced from BSE-free herds in New Zealand.

"Records relating to the seventh batch do not fully clarify the BSE-free status of the veterinary-controlled UK herd , although there is no evidence to suggest that the herd was infected."

Celltech is believed to have told the Department of Health about concerns surrounding the sourcing of the vaccine albumen in August, at least a month after the last batch of vaccine left the Medeva facility in early July .

"We share the medical control agency's views that any risks from this vaccine are incalculably small. It does not arise from a vaccine component primarily manufactured by Celltech or the former Medeva," Celltech said.

The Medicines Control Agency (MCA) today ordered the recall of the remaining stocks of one brand of the oral polio vaccine used in the routine childhood vaccination programme and travel vaccination.

As nationwide supply of polio vaccine has already switched to a different manufacturer, the impact of the recall on the polio vaccination programme is likely to be minimal.

The recall is based on the discovery of a breach of European guidelines issued in 1999 as a precautionary measure to protect public health in the light of developing information about the theoretical transmission of BSE.

The 1999 guidelines made clear that the manufacturing process for oral medicinal products should not use bovine materials from countries in which there are known cases of BSE. The first guidance on this subject, issued by the Committee on Safety of Medicines in 1989, asked that UK-sourced bovine materials should not be used in the manufacture of injectable medicinal products.

(UK Correspondent's note: what this really says is that it has been acceptable and legal to use UK sourced bovine material in vaccines taken orally until 1999, from 1999 to now it has been against guidelines but legal, from March 2001 it will be illegal - oops - that's not until next year!!!!!!! Backhanders all round at MAFF & DoH!)

The implementation of this guidance by the MCA led to a phasing out during the early 1990s of vaccines that had used UK-sourced bovine material in their manufacture. From 1989 onwards, the MCA had sought and received assurances from drug companies that they were implementing this guidance. The MCA has now advised Ministers that in the case of the Medeva oral polio vaccine the assurances by the company have proven inaccurate. This particular oral polio vaccine was manufactured using a growth medium containing material of UK bovine origin. This specifically breaches the 1999 guidance which in March 2001 is expected to have the full force of law .

The Chief Medical Officer, Professor Liam Donaldson has written to all GPs today advising them of the recall. He said:

"The European guidelines were introduced in 1999 as a further precautionary measure to protect public health as knowledge grew about BSE. As another precautionary measure today we are recalling the existing stocks of the Medeva vaccine."

"Parents, children and people travelling abroad will now receive an alternative vaccine made by a different manufacturer. Stock levels for this other vaccine are already high and there should be minimal disruption to appointments."

"I know that this recall will worry parents but it is important to remember that polio is a potentially lethal disease which we have virtually eliminated from this country. As late as 1955 there were nearly 4,000 cases in England and Wales. Only by keeping our children vaccinated can we ensure it does not return to this country."

"I am advised that the risk of a person contracting vCJD from this oral polio vaccine is incalculably small.

"However, public confidence in medicines safety is paramount. We have to approach this from a precautionary principle, knowing that these important guidelines have been breached. The vaccine will be recalled immediately and replaced with a vaccine from another manufacturer which meets all safety requirements."

NOTES FOR EDITORS

1. The vaccine concerned was manufactured by Medeva from 1991 until production ceased in September this year. Between 1989 and 1991 it was produced by Wellcome.

2. GPs are being contacted today by the Department of Health to advise that, as a precautionary measure, all stocks of the Medeva oral polio vaccine should be withdrawn immediately. GPs will be supplied with the replacement vaccine made by Smith Kline Beecham as quickly as possible. SKB have confirmed that they have sufficient supplies to meet demand, although this may mean smaller but more frequent deliveries.

3. Anyone who has concerns about the vaccine can contact NHS Direct on 0845 4647, or visit the NHS Direct website at http://www.nhsdirect.nhs.uk.

[ENDS]

20 Oct 00 - CJD - Polio vaccine in BSE scare

Staff Reporter

BBC ... Friday 20 October 2000

Health officials say the risk to patients is "incalculably small"

A brand of polio vaccine routinely given to children has been withdrawn over fears it could be contaminated with BSE .

The Department of Health has told doctors not to use the Medeva brand of polio vaccine after it found the maker had breached CJD safety guidance.

But "hundreds of thousands" of doses of vaccine produced in breach of these guidelines have already been given to patients.

Calf foetuses from the UK were used to make the vaccine, and while officials say the vCJD risk to patients is "incalculably small", it is recalling all remaining stocks as a precaution.

Oral polio vaccine is routinely given to children - often in the form of a "sugarlump" - and travellers visiting certain countries.

Vaccine manufacturer Medeva had given assurances that none of its products had been made using beef tissue, in accordance with European guidance issued following of the BSE scare.

However, the Medicines Control Agency discovered that chemicals derived from cattle tissue had been used by Medeva to make this vaccine.

Precaution

The agency has told doctors to reassure patients that the recall is purely a precaution, as the ingredient, foetal calf serum, has never yet been found to have a capacity to infect humans with vCJD, although there may be a "theoretical" risk.

In addition, they say, part of manufacturing process aims to wash off unwanted cattle proteins which may harbour any potentially infectious agents.

"I know that this recall will worry parents , but it is important to remember that polio is a potentially lethal disease which we have virtually eliminated from this country.

"As late as 1955 there were nearly 4,000 cases in England and Wales. Only by keeping our children vaccinated can we ensure it does not return to this country."

He said that scientists had worked out that only a single hundred millionth of a mililitre of bovine material could be possibly passed on in a dose of vaccine.

He said: "It's not something that is an active ingredient of the vaccine but tiny traces can be carried forward into the vaccine itself."

However, vaccine safety campaigners say the revelation should reawaken debate on the way they are manufactured.

Ann Coote, a spokeswoman for JABS, a self-help group for people worried about vaccines, said: "This will scare parents. They will want to know: `Why weren't we told before? What really is the risk?'

"The Government always says the risks are minimal , but we won't know , will we, until and unless someone gets the human form of BSE from it."

GP Peter Skolar predicted chaos at GP surgeries as parents came to be reassured about the risks.

He said: "These are questions which in all honesty I can't answer."

The MCA has checked with other polio vaccine manufacturers, and found they were complying with the 1999 European guidance which advised against the use of cattle products from any country with a reported case of BSE.

SmithKline Beecham, which makes its own vaccine, says it has sufficient supplies to cover the shortfall, although there may be short term supply problems.

Patients worried about whether they have been given the vaccine should contact their GP, who will hold records of which brand of vaccine has been given.

Alternatively, they can call the NHS Direct helpline on 0845 4647.

20 Oct 00 - CJD - Polio vaccine recalled in BSE alert

Staff and agencies

Guardian ... Friday 20 October 2000

A polio vaccine regularly used to inoculate children and travellers was today recalled amid fears over BSE .

The risks to humans of catching CJD - the human form of BSE - was "incalculably small", the Department of Health has said.

GPs were being advised that, as a precautionary measure, all stocks of the Medeva oral polio vaccine should be withdrawn immediately , with replacement supplies made by Smithkline Beecham being brought in as quickly as possible.

Health chiefs said there had been a breach of health guidelines in the manufacture of the vaccine. European rules say oral medicinal products should not use bovine materials from countries in which there are known cases of BSE.

The Department of Health said the recall affected only one particular brand of polio vaccine, which was due to be replaced anyway.

A spokesman said: "As the national supply of polio vaccine has already switched to a different manufacturer, the impact of the recall on the polio vaccination programme is likely to be minimal."

Smith Kline Beecham confirmed it has sufficient supplies to meet demand, the health department said, though this may mean smaller but more frequent deliveries.

The recall is based on the discovery of a breach of European guidelines issued in 1999 as a precautionary measure to protect public health in the light of developing information about the theoretical transmission of BSE.

The first guidance, issued by the Committee on Safety of Medicines in 1989, asked that UK-sourced bovine materials should not be used in the manufacture of injectable medicinal products.

The implementation of this guidance led to a phasing out during the early 1990s of vaccines that had used UK-sourced bovine material in their manufacture. From 1989 onwards, the MCA had sought and received assurances from drug companies that they were implementing this guidance.

The chief medical officer, Professor Liam Donaldson, has written to all GPs today advising them of the recall.

He said: "I know that this recall will worry parents , but it is important to remember that polio is a potentially lethal disease which we have virtually eliminated from this country.

"As late as 1955 there were nearly 4,000 cases in England and Wales. Only by keeping our children vaccinated can we ensure it does not return to this country.

Anti-vaccine campaigners said the recall was another example of the hidden dangers of inoculations.

Ann Coote, a spokeswoman for JABS, a self-help group for people worried about vaccines, said: "This will scare parents. They will want to know: 'Why weren't we told before? What really is the risk? '

"The government always says the risks are 'minimal' , but we won't know, will we, until and unless someone gets the human form of BSE."

20 Oct 00 - CJD - Polio vaccinations

Mark Oliver

Guardian ... Friday 20 October 2000

The health authorities are trying to calm fears over whether polio vaccinations have been infected with CJD.

What is the scare about?

An oral polio vaccine, Medeva, has been recalled amid fears over CJD, the human form of BSE or "mad cow disease". Medeva is partly made up of bovine materials from the UK , where there have been cases of BSE. The fear is the vaccine may include BSE contaminated traces. The guidelines that should ensure suspect medicines are prohibited have been breached, and the discovery of this fact by the Medical Controls Agency has triggered today's recall.

What are the risks of this vaccine giving someone CJD?

"Incalculably small" according to the Department of Health, which insists that the recall is a precautionary one and that the vaccine was due for replacement anyway. The vaccine contains tiny traces of a foetal calf growth serum, but this is classified under the European guidelines as in category IV, which stands for "no detectable ineffectively". Also, the manufacturing processes used to make the vaccine are designed to remove the serum. The Department of Health stress that it is balance of these points which makes them confident it is unlikely anyone will contract BSE from the vaccine.

How widely is Medeva used?

It has been given to hundreds of thousands of patients , usually on sugar cubes, to children or travellers. The vaccine has been used since the early 1980s and, up until this September, accounted for a third of all polio inoculations. Alternatives are available and supplies by Smith Kline Beecham are being increased with haste.

How has this happened?

It is not yet clear exactly how the vaccine has remained in use, but the government have said that assurances were repeatedly "sought and received" from Medeva that they were implementing new guidelines on bovine materials that came into force last year. The Department of Health, whose suspicions were raised in June, have said that they now know these assurances were inaccurate . Medeva today said they were preparing a statement on the recall.

What is the advice for people who are concerned?

GPs are being advised by the Department of Health on the scare, and the NHS Direct call line (0845 4647 ) can answer specific anxieties. The government have told doctors that immunisation programmes should continue with alternative vaccines. If you or your child have had a Medeva vaccination, there is no urgent need to have any kind of check up, as the current advice is that there is such a tiny risk of contracting BSE.

Are there other concerns?

The fears of the British Polio Fellowship are that the scare might deter people from being vaccinated. In a statement, the fellowship said that there was still a "real risk" of polio and cited a case in Holland a few years ago where a religious community decided against vaccinations and there was an epidemic. They also called for more stringent monitoring processes on BSE risks.

20 Oct 00 - CJD - Polio vaccine recalled in BSE scare

Staff Reporter

Independent ... Friday 20 October 2000

Stocks of an oral polio vaccine have been recalled amid fears over mad cow disease.

A breach of regulations regarding the use of UK bovine material is being blamed for the alert.

European rules say oral medicinal products should not use bovine materials from countries in which there are known cases of BSE.

A spokesman for the Department of Health said: "As the national supply of polio vaccine has already switched to a different manufacturer, the impact of the recall on the polio vaccination programme is likely to be minimal."

The risks to humans of catching CJD - the human form of BSE - was "incalculably small", the department said.

In a letter to GPs, Chief Medical Officer, Professor Liam Donaldson, said: "I am advised that the risk of a person contracting vCJD from this oral polio vaccine is incalculably small.

"However, public confidence in medicines safety is paramount. We have to approach this from a precautionary principle, knowing that these important guidelines have been breached.

Shadow health secretary Liam Fox said: "The immunisation programme is one of the most important parts of public health policy.

"It is an area in which we have experienced shortages of vaccine for tuberculosis and influenza and a lack of openness about the safety of meningitis C and it has not been well-handled by current ministers.

"It is therefore essential that all information is fully disclosed by the Government to help retain the confidence of an understandably sceptical public."

Liberal Democrat health spokesman Nick Harvey said: "It is crucial that children continue to be vaccinated. Polio is a far more serious threat to children's health than the small risk of BSE.

"But the Government's vaccine programme is in confusion and disarray .

"This latest scare raises serious questions about the lack of transparency and accountability in the vaccine programme . The Government must now prove that vaccines are safe ."

20 Oct 00 - CJD - Polio vaccine recalled after BSE scare

Staff Reporter

Telegraph ... Friday 20 October 2000

Health chiefs have withdrawn a Polio vaccine used to innoculate children and travellers amid fears over mad cow disease.

The government announced today that there had been a breach of European rules in the manufacture of the vaccine; health guidelines say that oral medicinal products should not use bovine materials from countries in which there are known cases of BSE.

A Department of Health official said the recall affected only one particular brand of polio vaccine, which was due to be replaced anyway. All remaining stocks are being recalled. He added that the risk to humans of catching CJD, the human form of mad cow disease, was "incalculably small".

20 Oct 00 - CJD - mad cow alert on polio vaccine

by Charles Reiss and Richard Allen

Evening Standard ... Friday 20 October 2000

Hundreds of thousands of doses of polio vaccine were recalled today amid fears that some could be contaminated by mad cow disease .

The Government's chief medical officer, Professor Liam Donaldson, has written to all GPs advising that existing stocks of the Medeva vaccine, widely used to inoculate children and travellers, should be withdrawn immediately .

Professor Donaldson said that the risk of contracting CJD, the human variant of BSE, was "incalculably small". But he added the company had clearly breached health guidelines , issued as early as 1989, urging that material from cows or calves should not be used in drugs . Bovine material is used in the growth medium in which the vaccine is produced.

In what threatens to become a major scandal, Professor Donaldson also said that the company concerned had given "inaccurate" assurances to the authorities that the guidelines were being observed.

The Health Department was unable immediately to say exactly how many doses are involved in today's recall. Medeva ceased producing the vaccine last month for reasons, it was said, unconnected with the current problem.

'We estimate hundreds of thousands of Medevavaccinations have been administered' - said a Health department official.

Suspicions were raised in June that the guidelines were being breached and further investigations revealed that UK-sourced foetal calf serum was being used as a growth agent in the vaccine .

A Department of Health spokesman said: "Since 1999 , when Medeva have been in breach of the guidelines, we estimate hundreds of thousands of Medeva vaccinations have been administered . This product had been used prior to that for 10 years . The company produced around 11 million doses .

"The bovine material is not in the final product that is given orally to anybody. Vaccines are generally made using bovine material but it is no longer UK sourced. The manufacturer has stopped making this vaccine but there will still be thousands of remaining stocks so we are asking GPs not to use them from today.

"We don't think it was a conspiracy to mislead by the manufacturers but a genuine mistake in their organisation. But yes, they did give false assurances to our department.

"Checks had already been made and it was only when we did further checks in July and August that this came to light. It was not until this month that we were able to confirm this."

Official embarrassment about today's disclosure is intensified , because next week the official report on BSE will be published, exposing years of Whitehall concealment of the scandal .

The vaccine concerned, which is given by mouth, was made by Wellcome between 1989 and 1991 and after that by Medeva until production ceased.

A statement from the government said that the recall was "based on the discovery of a breach of European guidelines ". It also said that the original warning came from the Health Department's own Committee on Safety of Medicines in 1989.

This asked "that UK-sourced bovine materials should not be used in the manufacture of injectable medicinal products ".

As a result, vaccines using material from cows or calves in the UK were phased out in the early Nineties.

The statement goes on: "From 1989 onwards, the Medicines Control Agency had sought and received assurances from drug companies that they were implementing this guidance. The MCA has now advised ministers that in the case of the Medevaoral polio vaccine the assurances by the company have proven inaccurate .

"This particular vaccine was manufactured using a growth medium containing material of UK bovine origin . This specifically breaches the 1999 guidance which in March, 2001, is expected to have the full force of the law." Prof Donaldson said today that the stocks had been withdrawn as a "precautionary measure".

He said that parents, children and travellers would be given an alternative from a different manufacturer, adding that stock levels of the other vaccine were already high.

Prof Donaldson added: "I am advised that the risk of a person contracting CJD from this oral polio vaccine is incalculably small. However, public confidence in medicines safety is paramount. We have to approach this from a precautionary principle, knowing that these important guidelines have been breached."

Protection against polio is routinely given to children - often in the form of a sugar lump - and to travellers visiting certain countries.

Doctors are being told to reassure patients that the recall is purely a precaution, as the Medeva ingredient, foetal calf serum, has never yet been found to have a capacity to infect humans, although there maybe a "theoretical" risk.

In addition, the MCA says that part of the manufacturing process washes off unwanted cattle proteins which could harbour potentially infectious agents.

Checks have been carried out on other vaccine manufacturers and found that they have complied with the regulation banning use of cattle products from any country with a reported case of BSE.

The substitute vaccine will come from SmithKline Beecham, which says it has sufficient quantities to cover the shortfall, though there maybe short-term supply problems.

• One of Britain's biggest biotechnology company, Celltech, came under the hammer falling 54p to 1328p in the mistaken belief that it was the supplier of a polio vaccine that has been withdrawn.

Celltech bought rival Medeva, which produced the vaccine until last month, for £554 million last year, but sold the vaccines part of the business to Powderject last month.

20 Oct 00 - CJD - What is the risk of polio?

by Zoe Morris and Richard Allen

Evening Standard ... Friday 20 October 2000

Question and Answer

Polio is a crippling, potentially deadly and highly contagious disease. As late as 1955, there were nearly 4,000 cases in England and Wales. However, since then it has been virtually eradicated through a programme of vaccination for children. Routine vaccination was introduced in 1956 and the oral vaccine has been used from 1962.

Between 1985-95 there were only 19 cases, but in countries where vaccination has not been introduced epidemics still occur.

How many people are likely to have been given the Medeva vaccine?

Medeva produced around 11 million doses of oral polio vaccine. The proportion of those that have been given to toddlers and travellers depends on how many are in stocks in GPs' surgeries. However, the number of unused vaccine doses is expected to only be the hundreds. About 96 per cent of children are immunised against polio by their second birthday and travellers going to all areas except North and Western Europe, North America, Australia and New Zealand are advised to take the vaccine.

How would people know if they have had the Medeva vaccine?

The Department of Health stopped using polio vaccines produced by Medeva last month. However, the only way to be sure about which vaccine was given is to check with your GP or practice nurse. The British Medical Association said today that GPs were expecting to be inundated with calls. GP surgeries have to record batch numbers when they receive supplies of vaccines, so should be able to trace the period during which any Medeva vaccines were being used.

What steps should people take if they have been given the vaccine?

Anyone concerned they or their child may have been given a Medeva vaccine is advised to call the Department of Health helpline NHS Direct on 0845 4647. Nurses on the advice line have been instructed to tell callers that the risk of developing CJD is "minuscule", but suggest anyone who is still concerned should contact their GP. There is little that can be done for patients who have received the Medeva vaccine, as the incubation for CJD is still not clear and could be up to 20 years.

Why didn't the Government ban bovine materials in 1989 instead of issuing guidelines?

Guidelines could be issued much more quickly than bringing in a ban which would require legislation. It was felt the guidelines carried sufficient legal sanction in that the product had to be legally licensed. If the guidelines are breached, then the licence to sell the product can be withdrawn. However in March 2001 the guidelines are expected to have the full force of law.

Were the companies Wellcome and Medeva guilty of negligence by ignoring the guidelines?

The Medicines Control Agency has criticised the vaccine's manufacturers for failing to keep the Government informed. A spokesman said the MCA had advised ministers that assurances by the company that they were following the 1999 guidelines "have proven inaccurate" . However the Health Department does not suspect a conspiracy to mislead the authorities but believes it was "a genuine mistake".

What happens in other countries? The guidelines issued last year apply across the EU. They prohibit use of bovine materials from countries with known cases of mad cow disease in oral medical products.

Are any other forms of vaccines suspect?

The Department of Health said today that it was "entirely happy" with the assurances given about other vaccines. There are no plans to investigate any other medicines or drugs produced by Medeva.

20 Oct 00 - CJD - BSE advisers see danger in European beef

James Meikle and Jon Henley in Paris

Guardian ... Friday 20 October 2000

The government's advisers on BSE risked starting a new row with France yesterday when they suggested British beef was now safer than that in other European countries and that tourists should be told of potential risks of catching the human form of the disease from infected cows abroad .

Harriet Kimbell, the consumer representative on a committee made up mostly of scientists, said she had made a personal decision not to let her family eat French beef or beef products on holiday, but ministers should stop short of telling other people to follow suit.

"I would like information in the public domain so people can make their own choices ," she said. "People should be made aware of countries where BSE is increasing.

"I would not have the British government saying, 'Don't eat beef in France.' I made up my mind for my family. I would not dream of telling everyone else what to do for their particular families."

Mrs Kimbell, who lectures at the College of Law, Guildford, and is deputy chairwoman of the Consumers' Association, said she had stopped her sons, Andrew, 17, and Ben, 14, eating beef when on holiday in the French Alps last year. She had taken them round the buffet in the dining room at the centre where they were staying and "told them what to eat and what not to eat".

Tourists and other Britons travelling abroad should, she said, "be made aware that it may well be British beef is safer than beef in some European countries , and then they can make up their own mind if they want to incur the risk of eating beef elsewhere ".

Peter Smith, acting chairman of the spongiform encephalopathy advisory committee, said he "did not feel uncomfortable" eating British beef, although animals in other countries might be going into the food chain further into the BSE incubation period. There was a "cogent case" that British beef might now be safer than that in other countries even if the size of their epidemics was far smaller, he added.

The committee has asked the food standards agency to review checks that beef from cattle infected with the disease, but not showing outward signs, is not slipping into Britain illegally . All European countries are now required to ban parts of cattle thought to be most at risk of spreading BSE infection to humans, but in addition Britain bans all animals more than 30 months old, including imports from countries with BSE.

The food agency said there were no grounds to advise against consumption of legally sold EU beef, while a source at the French agriculture ministry said people were entitled to their point of view.

He added: "We do not pretend that our preventative measures against BSE are perfect and we are ceaselessly improving them in consul tation with our scientists."

France, which has refused to lift its ban on British beef and has reported more than 150 cases of BSE in all - including 71 so far this year - exports nearly 5,000 tonnes a year to the UK. Ireland, where there have been 500 BSE cases, is Britain's biggest supplier, sending 77,000 tonnes annually. Other countries with BSE include Portugal, where there have been 452 cases, and Switzerland, where there have been 359 cases.

Despite the decline in the BSE epidemic in Britain, there have already been 962 cases this year, bringing the total to 177,314 . Many thousands of infected animals are thought to have entered the food chain during the late 1980s before the first BSE controls were introduced.

Last year Britain still had 472 BSE cases for every million cattle more than 24 months old. France had 2.8 for every million.

Most animals struck down by BSE are far older than 30 months and scientists in the UK now believe that only one British cow a year over 30 months, and likely to display BSE if not killed, is slipping through the net.

The advisory committee has also recommended new experiments to ensure pigs and poultry cannot carry "hidden BSE" and infect people eating their meat . Tests in the early 1990s suggested this was not possible but new research using mice and hamsters injected with a BSE-like disease has reawakened fears .

20 Oct 00 - CJD - Britons told to avoid French beef

By Valerie Elliott Consumer Editor

Times ... Friday 20 October 2000

The British public should be warned of the possible dangers of eating French beef , a government adviser on "mad cow" disease said yesterday.

Professor Harriet Kimbell, the consumer representative on the BSE advisory committee, said she would not eat it and on holiday in France had ordered her teenage sons not to touch beef.

She spoke out after BSE experts on the Spongiform Encephalopathy Advisory Committee (SEAC) raised concerns that continental beef from cattle aged more than 30 months might even be imported into Britain and entering the food chain.

The experts are concerned about risks from European countries - in particular, France , Portugal , Ireland and Switzerland - which did not have the same strict controls as Britain. They fear that people on the Continent or British holidaymakers have a greater chance of eating meat from a cow that might be incubating the disease . Professor Kimbell's remarks threaten to reignite the war of words between Britain and France over the French refusal to accept British beef exports or for it to be used in French restaurants or sold in their supermarkets.

She revealed yesterday that on holiday in the French Alps last summer she had ordered her two sons Ben, 17, and Andrew, 14, not to eat beef when they helped themselves from the restaurant buffet.

Professor Kimbell, principal law lecturer at Guildford College of Law, said: "I took my sons to Club Med. I told them what was beef and what they were to help themselves to. I instructed them not to eat beef. They were upset. Tourists should be made aware that it may well be that British beef is now safer than it is in some other European countries ."

Professor Peter Smith, acting chairman of SEC, said there was "a cogent case" to say that French beef posed a higher risk than British beef.The experts believe that some beef from older cattle imported into Britain could be finding its way into the food chain . They issued a warning that there was no way of identifying such meat unless inspectors from the Meat Hygiene Service or the Government's vets working at ports uncovered such an illegal trade.

20 Oct 00 - CJD - Cow remains 'permitted' in French cattle feed

By John Lichfield in Paris

Independent ... Friday 20 October 2000

Further evidence emerged yesterday that France ignores its own purported policy of zero tolerance of the risks associated with BSE , or mad cow disease.

Liberation, a French newspaper, reported that traces of the ground-up remains of cows were permitted in French cattle feed , despite an official ban going back 10 years.

For the past two years, French customs and fraud officers have been ordered to allow the use of compound cattle feeds containing 0.3 per cent or less of minced and dried remains of cows and other grazing animals. The presence of cow remains in cattle feed is blamed for the epidemic of BSE in Britain. It has been banned from cattle feed in all European Union countries since 1990.

The French feed industry argues that it is difficult to test the contents of cattle feed to an accuracy of less than 0.3 per cent. Feed manufacturers also say it is impossible to guarantee that feed is 100 per cent clear of cattle remains. Unlike the UK, France continues to allow the use of dried cattle remains in feed for pigs and hens .

Scientists have warned that BSE transmission through feed is a complex, ill-understood subject. Some animals can eat large quantities of suspect feed and not catch the disease; others might succumb to exposure to tiny amounts of infected feed.

The disclosure of an official French policy of "tolerance" of BSE risk - however small - undercuts the main argument used by Paris a year ago when it defied EU orders and imposed a unilateral ban on British beef imports. The French government said it had to pursue, where possible, a policy of zero risk with human health.

Since then a number of instances have emerged of French policy on BSE taking risks when tighter controls might damage agricultural or food trade interests. A French consumers' association yesterday called on the government to "stop taking risks with human health" and ban use of cattle remains in all animal feed.

Claims earlier this week that French beef is now less safe than British have been dismissed as misleading by French officials, who say that France has had only 152 cases of BSE in the past decade compared with 180,000 in Britain.

19 Oct 00 - CJD - Better late than never

Food Standards Agency

Guardian ... Thursday 19 October 2000

2000/0053

Thursday 19th October 2000

REVIEW OF BSE CONTROLS TO CONSIDER ANIMAL BLOOD AND 'PRIVATE KILLS'

The review of BSE controls by the Food Standards Agency is to consider any public health issues that may arise from the possible use of animal blood in animal feed , and the practice of private kills on farms.

The Agency began its review of BSE controls in April this year and the issue of private kills was raised during the public consultation process.

Geoffrey Podger, Chief Executive of the Food Standards Agency, said: Our review of BSE controls was intended to be thorough and exhaustive. With the benefit of full public consultation, we have identified a number of issues where we need to ensure that the facts are clearly established. If there are any public health risks associated with these issues then the review will consider them very carefully.

There have been four public meetings to consider the review of BSE controls. A fifth meeting is scheduled for 2nd November, after which the final draft of the report of the review will be considered by the Board of the Food Standards Agency.

At a Press briefing given today by the Spongiform Encephalopathy Advisory Committee (SEAC), questions were raised about enforcement of the Over Thirty Month (OTM) Rule in relation to imported meat.

There is a ban on the sale of foreign OTM meat for human consumption, except for 14 listed countries where there is not believed to be a risk.

There have been allegations of companies importing beef - likely to be from OTM animals - for sale for human consumption. The Agency has followed up all allegations that have been made, and will vigorously pursue any future allegations.

The Meat Hygiene Service enforces OTM rules in slaughterhouses and meat cutting plants. Local authorities are responsible for enforcement in all other premises.

The British public should be warned of the possible dangers of eating French beef , a government adviser on "mad cow" disease said yesterday.

Professor Harriet Kimbell, the consumer representative on the BSE advisory committee, said she would not eat it and on holiday in France had ordered her teenage sons not to touch beef.

She spoke out after BSE experts on the Spongiform Encephalopathy Advisory Committee (SEAC) raised concerns that continental beef from cattle aged more than 30 months might even be imported into Britain and entering the food chain .

The experts are concerned about risks from European countries - in particular, France, Portugal, Ireland and Switzerland - which did not have the same strict controls as Britain. They fear that people on the Continent or British holidaymakers have a greater chance of eating meat from a cow that might be incubating the disease. Professor Kimbell's remarks threaten to reignite the war of words between Britain and France over the French refusal to accept British beef exports or for it to be used in French restaurants or sold in their supermarkets.

She revealed yesterday that on holiday in the French Alps last summer she had ordered her two sons Ben, 17, and Andrew, 14, not to eat beef when they helped themselves from the restaurant buffet.

Professor Kimbell, principal law lecturer at Guildford College of Law, said: "I took my sons to Club Med. I told them what was beef and what they were to help themselves to. I instructed them not to eat beef. They were upset. Tourists should be made aware that it may well be that British beef is now safer than it is in some other European countries."

Professor Peter Smith, acting chairman of SEC, said there was "a cogent case" to say that French beef posed a higher risk than British beef .The experts believe that some beef from older cattle imported into Britain could be finding its way into the food chain. They issued a warning that there was no way of identifying such meat unless inspectors from the Meat Hygiene Service or the Government's vets working at ports uncovered such an illegal trade.

French beef carries a greater risk of carrying mad cow disease than British beef and the public would be best advised not to eat it , a member of the Government's BSE advisory body said yesterday.

Prof Harriet Kimbell, a member of the Spongiform Encephalopathy Advisory Committee, which advises ministers on BSE and vCJD - the human form of BSE - said she would not eat beef from France or 13 other European countries or give it to her family.

Prof Kimbell, head of law at Guildford University and a former deputy chairman of the Consumers' Association, said: "When I took my sons on holiday to the Mediterranean last year I instructed them not to eat the beef." Her sons Andrew, 17, and Ben, 14, were "very upset". She added: "Tourists should be made aware that it may well be that British beef is now safer than it is in some other European countries." She had "no discomfort" about eating British beef.

The committee's acting chairman, Prof Peter Smith of the London School of Hygiene and Tropical Medicine, said that while Britain imposed a ban on imported meat from cattle over 30 months old entering the food chain, there were potential problems establishing the age of imported meat . He said the number of BSE cases was still rising in France and Portugal because those countries were slower in imposing controls on contaminated feed. The number of cases in Britain peaked in the early Nineties.

France - which refuses to lift its ban on British beef imports in defiance of an EC ruling - had 31 BSE cases last year and 71 so far this year. Portugal had 168 and Ireland 91, compared with 2,200 a year in Britain. However, Prof Smith said the risk of eating infectious material was greater with beef from other European countries because they did not remove all cattle over the age of 30 months from the human food chain.

He admitted that despite the ban on meat from these animals some might be reaching Britain. Asked if British beef was still a greater health risk than French beef, Prof Smith said: "I think one could make a cogent case for saying that the reverse is true."

Tim Yeo, the Conservative agriculture spokesman, said: "This exposes the hypocrisy of the French government's illegal ban on British beef."

The Food Standards Agency said that as the SEAC had not issued new advice it had no reason to advise against eating EU beef.

15 Oct 00 - CJD - Ministers considering payout to CJD victims

By Colin Brown, Political Editor

Independent ... Sunday 15 October 2000

Ministers have met secretly to consider the case for paying compensation to the victims of CJD, the human form of mad cow disease.

Alan Milburn, the Health Secretary, and senior officials have taken legal advice about the Government's liability for compensation for the victims, but Government sources are not ruling out "no-fault" compensation to the CJD victims, at a potentially vast cost to the public purse.

Ministers are braced for a public outcry when the Phillips inquiry into the BSE scandal is published at the end of the month. David Body, the lawyer representing many of the victims' families, said their case would be restarted after the publication of the report.

The Independent on Sunday has learned that the Government will resist admitting liability but the move to no-fault compensation could enable the victims and their families to be compensated for their needs without blame having to be established.

There are 84 known cases of the fatal disease so far. About half have dependent children and the families also need urgent help in caring for relatives who are left to cope with long, agonising illnesses.

Ministers were ready to blame the past Tory government for the scandal but now fear that it could open the floodgates to claims running into many millions of pounds.

However, having studied the report, they fear the present government will be held responsible for clearing up the mistakes of the past Tory administration for its mishandling of the BSE crisis.

One source who has read the report said: "It is a very well written report and it is very compelling reading. It names names."

The report contains a chapter spelling out the names of those it criticises for contributing to the tragedy by giving assurances about the safety of beef, which turned out to be false . It names past Tory ministers and officials at the Department of Health and the Ministry of Agriculture, Fisheries and Food including Stephen Dorrell , who will be criticised for being pressed into saying in a radio interview that beef was safe, and John Gummer , who fed his daughter with a burger to show that he believed beef was safe.

Those who have read the report, however, say that it will be difficult for the Government to escape some of the blame for the CJD tragedy, although the failure of smaller abattoirs to enforce stricter standards on offal will be seen as one "let out".

The Health Secretary privately discussed the options with senior officials last week. Agriculture minister Nick Brown and MAFF officials have been resisting compensation claims but Whitehall sources said Mr Brown was sympathetic to the case for paying compensation.

Ministers fear that the compensation demands could spiral if the number of cases continues to rise from the present total of 84 to unexpected levels . "The real problem is we don't know how many could be involved," said a Government source. "It could be 80 cases but what if it was eight million ? We just don't know."

The food standards watchdog, Sir John Krebs, yesterday suggested that BSE-infected meat could still be finding its way into food , 11 years after controls to prevent it.

He disclosed official fears that farmers were bypassing health checks on beef and other meat , and warned consumers to buy only from "reputable sources".

Sir John, chairman of the food standards agency, is trying to establish the extent before seeking tighter rules governing so-called private kills by farmers , and so that new rules on the use of unlicensed abattoirs can be considered by its board next month. His officials admit they have "anecdotal information" rather than evidence.

Vets voiced their concerns to the chief medical officer, Liam Donaldson, 18 months ago. But yesterday these concerns that beef and sheep products could slip through the anti-BSE net stunned members of the government's scientific watchdog , the spongiform encephalopathy advisory committee.

Seventy-seven people have so far died from the human form of the disease in Britain, seven others have been identi fied as having the fatal condition, and monthly bulletins show the number of victims to be rising steadily,

Peter Smith, chairman of the advisory committee, said: "I don't recall having any data on unlicensed sale of such meat. I don't recall it as being brought to our attention . If there was meat 'going round the back door' to consumers without going through existing controls, it would be of concern." Harriet Kimbell, consumer member of the committee, said: "I am shocked."

The Ministry of Agriculture declined to discuss whether the possible loophole had been considered in the ministry before the independent agency was founded in April, and referred all questions to the agency.

Farmers are allowed to kill animals for their own use and ignore the rule which bans most cows over 30 months old from entering human food .

Meat infected with BSE could still be finding its way into the human food supply because of a legal loophole , the chairman of the Food Standards Agency warned yesterday.

Sir John Krebs promised a tightening of the regulations after warning that farmers could be allowing meat that had not been inspected for the disease to reach the open market . Beef from animals killed on a farm or in an unlicensed abattoir for the owner or relatives to eat was exempt from the rules introduced to keep BSE out of the human food chain.

Cattle aged over 30 months were also deemed unfit for human consumption but the rule did not apply to meat from a private kill , he said. Sir John called for stronger safeguards to ensure such meat was not being made available for public consumption, particularly in rural areas.

There was no way of ensuring parts such as brains and spinal tissues - feared to be the most dangerous part of an infected animal - had been properly removed, he said. He told the BBC's Farming Today programme: "That's precisely why we're concerned about both the extent to which this goes on and the possibility that meat or meat products from private kills might get into the wider food chain.

"We want to make sure that in the longer term work is done to tighten up this loophole." The FSA said there was not enough information available to assess the scale of the problem, and advised consumers in rural areas to make sure any meat they bought was "from a reputable source".

Jill Newt, chairman of the Royal College of Veterinary Surgeons advisory group and its representative on the FSA's stakeholders group, said there was no doubt meat from private kills was entering the food chain .

She told the programme: "I think consumers should be aware that anyone offering them cheap meat should get a second look at where that animal was killed and where that meat was cut up. It's very important from a consumer point of view that people know where their meal came from and how it was handled."

Peter Scott, director of the British Meat Federation, which represents abattoirs, called for the end of the exemptions for privately killed animals . He said: "This is a problem for the Food Standards Agency and it's a dilemma which they, and before them the Ministry of Agriculture, have faced for a number of years.

"But our view hasn't changed. We believe, in this day and age, if there's any risk at all, then that loophole must be closed."